IL257279B2 - Anti-Epner 1 formulation is stable - Google Patents
Anti-Epner 1 formulation is stableInfo
- Publication number
- IL257279B2 IL257279B2 IL257279A IL25727918A IL257279B2 IL 257279 B2 IL257279 B2 IL 257279B2 IL 257279 A IL257279 A IL 257279A IL 25727918 A IL25727918 A IL 25727918A IL 257279 B2 IL257279 B2 IL 257279B2
- Authority
- IL
- Israel
- Prior art keywords
- antibody
- formulation
- months
- lysine
- storage
- Prior art date
Links
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| CN113474360A (zh) | 2019-02-18 | 2021-10-01 | 伊莱利利公司 | 治疗性抗体制剂 |
| CN110179746A (zh) * | 2019-05-17 | 2019-08-30 | 通化东宝生物科技有限公司 | 一种稳定的苏金单抗注射剂及其制备方法 |
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| CA3187785A1 (en) | 2020-06-25 | 2021-12-30 | Medimmune Limited | Prevention of axonal damage using antibody binding to amyloid beta 1-42 |
| TW202237647A (zh) | 2020-10-08 | 2022-10-01 | 瑞典商阿斯特捷利康公司 | 狼瘡發作之治療 |
| CN117157099A (zh) * | 2021-04-23 | 2023-12-01 | 阿斯利康(瑞典)有限公司 | 用于皮下注射的抗ifnar1给药方案 |
| JP7484027B2 (ja) | 2021-04-23 | 2024-05-15 | アストラゼネカ・アクチエボラーグ | 皮下注射のための抗ｉｆｎａｒ１投薬計画 |
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| WO2022223771A1 (en) | 2021-04-23 | 2022-10-27 | Astrazeneca Ab | Treatment of lupus nephritis with anti-type i inf receptor antibody anifrolumab |
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| CN113521276B (zh) * | 2021-07-13 | 2022-04-12 | 江苏荃信生物医药股份有限公司 | 包含抗人干扰素α受体1(IFNAR1)单克隆抗体的液体制剂 |
| CN113527490B (zh) * | 2021-07-13 | 2022-03-01 | 江苏荃信生物医药股份有限公司 | 一种抗人ifnar1单克隆抗体浓缩溶液的制备方法 |
| WO2023284073A1 (zh) * | 2021-07-13 | 2023-01-19 | 江苏荃信生物医药股份有限公司 | 降低单克隆抗体生产中宿主细胞蛋白含量的亲和纯化方法、抗人ifnar1单克隆抗体浓缩溶液的制备方法以及液体制剂 |
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| CA3234358A1 (en) * | 2021-10-29 | 2023-05-04 | Intas Pharmaceuticals Ltd. | Stable lyophilized formulation of an anti-.alpha.4.beta.7 antibody |
| WO2023155902A1 (en) * | 2022-02-18 | 2023-08-24 | Chongqing Mingdao Haoyue Biotechnology Co., Ltd. | Intranasal formulations and anti-sars-cov-2-spike protein antibodies |
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009070642A1 (en) * | 2007-11-28 | 2009-06-04 | Medimmune, Llc | Protein formulation |
| WO2009100309A2 (en) * | 2008-02-08 | 2009-08-13 | Medimmune, Llc | Anti-ifnar1 antibodies with reduced fc ligand affinity |
| US7662381B2 (en) * | 2004-06-21 | 2010-02-16 | Medarex, Inc. | Interferon alpha receptor 1 antibodies and their uses |
| WO2010056804A1 (en) * | 2008-11-12 | 2010-05-20 | Medimmune, Llc | Antibody formulation |
| WO2014186350A1 (en) * | 2013-05-15 | 2014-11-20 | Medimmune Limited | Purification of recombinantly produced polypeptides |
| WO2015063180A1 (en) * | 2013-10-29 | 2015-05-07 | Novozymes Biopharma Dk A/S | Antibody composition |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4816567A (en) | 1983-04-08 | 1989-03-28 | Genentech, Inc. | Recombinant immunoglobin preparations |
| US6713609B1 (en) * | 1996-07-16 | 2004-03-30 | Genentech, Inc. | Monoclonal antibodies to type I interferon receptor |
| JO3000B1 (ar) * | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| CN101553504A (zh) * | 2006-12-11 | 2009-10-07 | 豪夫迈·罗氏有限公司 | Aβ抗体胃肠外制剂 |
| US7951368B2 (en) * | 2007-06-25 | 2011-05-31 | Amgen Inc. | Compositions of specific binding agents to hepatocyte growth factor |
| US20110152188A1 (en) * | 2009-12-23 | 2011-06-23 | Hanns-Christian Mahler | Pharmaceutical compositions of igf/i proteins |
| US20110223208A1 (en) * | 2010-03-09 | 2011-09-15 | Beth Hill | Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations |
| KR20140103099A (ko) * | 2011-10-12 | 2014-08-25 | 아센디스 파마 옵탈몰로지 디비젼 에이/에스 | 안구 병태의 예방 및 치료 |
| EP2771033A4 (en) * | 2011-10-28 | 2016-02-17 | Integritybio Inc | PROTEIN FORMULATIONS CONTAINING AMINO ACIDS |
| US9592297B2 (en) | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| US8883979B2 (en) | 2012-08-31 | 2014-11-11 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
| BR112015008186A2 (pt) | 2012-10-25 | 2017-09-19 | Medimmune Llc | formulação de um anticorpo estável e de baixa viscosidade |
| RU2675824C2 (ru) * | 2013-09-11 | 2018-12-25 | Игл Байолоджикс, Инк. | Жидкие белковые составы, содержащие ионные жидкости |
| EP3188757A1 (en) | 2014-09-03 | 2017-07-12 | Medimmune Limited | Stable anti-il-4r-alpha antibody formulation |
| WO2016109822A1 (en) | 2014-12-31 | 2016-07-07 | Novelmed Therapeutics, Inc. | Formulation of aglycosylated therapeutic antibodies |
| SI3337502T1 (sl) | 2015-08-19 | 2020-10-30 | Astrazeneca Ab | Stabilna formulacija proti-IFNAR1 |
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Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7662381B2 (en) * | 2004-06-21 | 2010-02-16 | Medarex, Inc. | Interferon alpha receptor 1 antibodies and their uses |
| WO2009070642A1 (en) * | 2007-11-28 | 2009-06-04 | Medimmune, Llc | Protein formulation |
| WO2009100309A2 (en) * | 2008-02-08 | 2009-08-13 | Medimmune, Llc | Anti-ifnar1 antibodies with reduced fc ligand affinity |
| WO2010056804A1 (en) * | 2008-11-12 | 2010-05-20 | Medimmune, Llc | Antibody formulation |
| WO2014186350A1 (en) * | 2013-05-15 | 2014-11-20 | Medimmune Limited | Purification of recombinantly produced polypeptides |
| WO2015063180A1 (en) * | 2013-10-29 | 2015-05-07 | Novozymes Biopharma Dk A/S | Antibody composition |
Non-Patent Citations (9)
| Title |
|---|
| AGARKHED, MEERA, ET AL., EFFECT OF POLYSORBATE 80 CONCENTRATION ON THERMAL AND PHOTOSTABILITY OF A MONOCLONAL ANTIBODY., 14 November 2012 (2012-11-14) * |
| AKERS, MICHAEL J., VASU VASUDEVAN, AND MARY STICKELMEYER., FORMULATION DEVELOPMENT OF PROTEIN DOSAGE FORMS., 31 December 2002 (2002-12-31) * |
| CARPENTER, JOHN F., ET AL., RATIONAL DESIGN OF STABLE LYOPHILIZED PROTEIN FORMULATIONS: SOME PRACTICAL ADVICE., 31 August 1997 (1997-08-31) * |
| KERWIN, BRUCE A., POLYSORBATES 20 AND 80 USED IN THE FORMULATION OF PROTEIN BIOTHERAPEUTICS: STRUCTURE AND DEGRADATION PATHWAYS., 1 August 2008 (2008-08-01) * |
| PENG, LI, ET AL., MOLECULAR BASIS FOR ANTAGONISTIC ACTIVITY OF ANIFROLUMAB, AN ANTI-INTERFERON–ALPHA RECEPTOR 1 ANTIBODY., 15 January 2015 (2015-01-15) * |
| SHARMA V K ET AL,, THE FOMULATION AND DELIVERY OF MONOCLONAL ANTIBODIES, 1 January 2009 (2009-01-01) * |
| SZYMCZYK, KATARZYNA, AND ANNA TARABA., AGGREGATION BEHAVIOR OF TRITON X-114 AND TWEEN 80 AT VARIOUS TEMPERATURES AND CONCENTRATIONS STUDIED BY DENSITY AND VISCOSITY MEASUREMENTS., 5 July 2016 (2016-07-05) * |
| WANG, WEI, ET AL., ANTIBODY STRUCTURE, INSTABILITY, AND FORMULATION., 1 January 2007 (2007-01-01) * |
| WANG, WEI., INSTABILITY, STABILIZATION, AND FORMULATION OF LIQUID PROTEIN PHARMACEUTICALS., 20 August 1999 (1999-08-20) * |
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